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Representatives of the Generic Pharmaceutical Association (GPhA) called on Congress to design a bipartisan biodefense bill that protects American consumers from painful increases in prescription drug costs caused by "needless brand product monopoly extensions."
In an appeal to the Senate Health, Education, Labor, and Pensions Committee, Kathleen Jaeger, president and chief executive officer of the GPhA, acknowledged "the need for policies to better prepare America in the event of a bioterrorist attack." She warned, however, that the legislation currently moving through the committee would grant branded pharmaceutical manufacturers "unearned monopolies at the expense of both preparedness and consumer savings."
According to Jaeger, "if this legislation remains in its current form, we would be condemning American consumers to pay higher prices for prescription medicines without improving the nation's overall preparedness." Instead of giving unwarranted patent extensions to brand name drug makers, the GPhA president urged the committee to focus on other incentives to promote the development of new means to combat bioterrorism, including product liability protections, expanded tax incentives, expedited FDA review, and guaranteed purchasing provisions.
Jaeger voiced particular objections to provisions in the pending bill that could extend monopolies on currently marketed drugs by as much as 10 years, and could redefine "orphan drug" exclusivity to extend beyond the "orphan indication of use" to the drug product itself.